Pune-based molecular diagnostics company Mylab Discovery Solutions Pvt Ltd, which specialises in molecular diagnostic kits has developed first made-in-India test kit for COVID-19 in a record time of six weeks. The kit — Mylab PathoDetect COVID-19 Qualitative PCR kit — is the first one to receive commercial approval from the Indian FDA/ Central Drugs Standard Control Organisation (CDSCO). Besides, Mylab is the only Indian company to have achieved 100 per cent sensitivity and specificity in the ICMR evaluation.
“With emphasis on ‘Make in India’ and support from local and central government, the COVID- 19 kit has been made as per WHO/CDC guidelines. It was developed and evaluated in a record time,” Hasmukh Rawal, Managing Director, Mylab Discovery Solutions said. He further added that the support and the immediate action from regulatory bodies (CDSCO/FDA), evaluation centre of ICMR, NIV, Biotechnology Industry Research Assistance Council (BIRAC) and the central and state governments during this national emergency is commendable.